Citation

Abstract

Introduction and objectives: Secukinumab, an antiinterleukin- 17A antibody was evaluated in two phase 3 clinical studies for efficacy and safety in subjects with moderate-to-severe plaque psoriasis. This analysis focuses on the sustainability of patient-reported outcomes (PRO) response with secukinumab treatment over time.

Materials and methods: Patients aged ?18 years were randomized 1:1:1 in ERASURE to subcutaneous treatment groups (secukinumab 150 mg, secukinumab 300 mg, and placebo) and 1:1:1:1 in FIXTURE (including an additional etanercept 50 mg twice-weekly group). Psoriasis clinical improvement was assessed by Psoriasis Area and Severity Index (PASI), and PROs were assessed with the Dermatology Life Quality Index (DLQI) and the visual analog scale (VAS) from the EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D). Sustained response was defined as ?PASI90 at week 24 and no psoriasis impairment (DLQI score of 0 or 1) maintained through week 52.

Results: Of the 572 subjects randomized to secukinumab 300 mg, 70% (398/572) achieved PASI90 at week 24. Of those achieving PASI90 at week 24, 81% (324/398) reported no psoriasis impairment (DLQI 0 or1). Of these subjects, 86% (278/324) sustained PASI90 and no psoriasis impairment at week 52. Similar findings were observed for sustained health status as measured by the EQ-5D VAS response – 91% of subjects who achieved clear or almost clear skin (PASI90) by week 24 and meaningful health status (an increase of 7 points or more on the EQ5D VAS) maintained both through 1 year.